U.S. patent application number 15/345932 was filed with the patent office on 2017-05-18 for systems and methods for providing comprehensive care for stoma patients.
The applicant listed for this patent is Vivante Health, Inc.. Invention is credited to Kimon Angelides.
Application Number | 20170140103 15/345932 |
Document ID | / |
Family ID | 58690074 |
Filed Date | 2017-05-18 |
United States Patent
Application |
20170140103 |
Kind Code |
A1 |
Angelides; Kimon |
May 18, 2017 |
SYSTEMS AND METHODS FOR PROVIDING COMPREHENSIVE CARE FOR STOMA
PATIENTS
Abstract
Embodiments of the invention include systems and methods for
providing comprehensive care for stoma patients. According to one
embodiment, a system for providing comprehensive care for a stoma
patient includes: a sensor device for detecting a fill level of an
ostomy bag fitted over and around a stoma, wherein the sensor
device is configured to sense one or more parameters of an effluent
received in the bag; communicating the measurements to a stoma care
management software application for formatting and visualization on
a patient mobile device; and transferring the formatted data to an
interactive wireless stoma care management platform, wherein the
platform is configured to maintain a patient related database and
to periodically advise the patient of needed actions as well as to
provide reminders, advice and coaching.
Inventors: |
Angelides; Kimon; (Houston,
TX) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Vivante Health, Inc. |
Houston |
TX |
US |
|
|
Family ID: |
58690074 |
Appl. No.: |
15/345932 |
Filed: |
November 8, 2016 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
62254475 |
Nov 12, 2015 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
G16H 10/60 20180101;
A61F 5/4404 20130101; G16H 40/67 20180101; G06F 19/3418 20130101;
G16H 80/00 20180101 |
International
Class: |
G06F 19/00 20060101
G06F019/00; A61F 5/44 20060101 A61F005/44 |
Claims
1. An ostomy bag having: a) an attachment site to a patient stoma;
b) at least one parameter sensor attached to the ostomy bag,
wherein the parameter sensor is configured to measure one parameter
of a stoma effluent received in the ostomy bag; and c) at least one
measurement communicator attached to the ostomy bag, wherein one
measurement communicator is configured to receive a measurement
data point from the parameter sensor and to communicate the
measurement data point to a stoma care management application.
2. The ostomy bag according to claim 1, further including a data
processor.
3. The ostomy bag according to claim 1, wherein an array of
parameter sensors are in communication with one measurement
communicator.
4. The ostomy bag according to claim 3, wherein the array of
parameter sensors are configured to take measurements at set timed
intervals.
5. The ostomy bag according to claim 1, wherein the parameter
sensor measures a percentage of an interior volume of the ostomy
bag filled, a volume of the bag contents, a temperature of the bag
contents, or a turbidity of the bag contents.
6. The ostomy bag according to claim 1, wherein the parameter
sensor and the measurement communicator are removably mounted on an
exterior of the ostomy bag.
7. The ostomy bag according to claim 1, wherein the parameter
sensor is embedded in the ostomy bag or embedded between an outside
elastomeric layer and an exterior surface of the ostomy bag and the
measurement communicator is removably mounted on an exterior of the
ostomy bag.
8. The ostomy bag according to claim 1, wherein the parameter
sensor communicates with the measurement communicator via a
communication conduit.
9. The ostomy bag according to claim 1, wherein the parameter
sensor is an olfaction sensor or a leakage sensor positioned
proximal a site where the ostomy bag is attached to a stoma.
10. A system for assisting a stoma patient with management of an
ostomy bag including: a) a sensor device configured to sense one or
more parameters of a stoma effluent received in the ostomy bag; b)
a stoma care management application for receiving, storing and
processing measurement data communicated from the sensor device,
wherein the stoma care management application is configured to run
on a patient mobile device; and c) a wireless platform in
communication with the mobile device, wherein the platform
comprises one or more portals, and wherein the platform is
configured to maintain a patient related database and a programmed
knowledge module for analyzing information from the database and
one or more external databases.
11. The system according to claim 10, wherein the sensor device
includes at least one parameter sensor that communicates a
measurement data point to a measurement communicator that is in
communication with the wireless device.
12. The system according to claim 10, further including a data
processor.
13. The system according to claim 10, wherein the mobile device
communicates with the stoma patient and the platform.
14. The system according to claim 13, wherein the platform is
configured to periodically advise the patient of needed actions as
well as to provide reminders, advice and coaching.
15. The system according to claim 14, wherein the platform is
configured to send queries to the patient and is capable of
receiving information from the patient and analyzing the received
information to provide the reminders, advice and coaching.
16. The system according to claim 14, wherein the platform is
configured to provide an alarm or message to let the patient know
before the stoma bag is at risk for overfilling or leaking.
17. The system according to claim 14, wherein the platform is
configured to correlate the sensor measurement data with a
predefined health metric for the stoma patient.
18. An interactive stoma care management platform comprising: a
memory; a processor that executes computer-executable components
stored in the memory to implement the platform, the
computer-executable components comprising: (i) a knowledge module
configured to analyze sensor measurement data received from a stoma
care management software application, wherein the stoma care
management software application is configured to run on a mobile
device; and (ii) a portal configured to add contextual metadata to
at least a subset of the analyzed sensor measurement data, wherein
the contextual metadata comprises one or more tags that identifies
an origin of the subset of analyzed sensor measurement data within
one or more sub-portals, wherein at least one sub-portal is
configured to communicate an intervention trigger to a mobile
device in dependence on the analyzed sensor measurement data
exceeding a predefined threshold level.
19. The platform according to claim 18, wherein the knowledge
module comprises computer program instructions for maintaining a
patient related database for storing the sensor measurement data
from the stoma care management software application.
20. The platform according to claim 18, wherein the knowledge
module comprises computer program instructions for determining a
correlation between the sensor measurement data and a predefined
health metric for the stoma patient.
21. The platform according to claim 18, wherein the contextual
metadata further comprises at least one of a unique identifier
associated with a collection bag for the stoma patient, the patient
name, a measurement time and a measurement date.
22. A non-transitory computer-readable medium having stored thereon
computer-executable instructions that, in response to execution,
cause a computing system to perform operations for stoma care
management, the operations comprising: interfacing with a sensor
device; and receiving, from the sensor device, a plurality of
sensor measurement data relating to one or more parameters
associated with an ostomy bag for a stoma patient.
23. The computer-readable medium according to claim 22, wherein the
operations further comprising: converting the received sensor
measurement data into a usable format; and presenting a visual
representation of the formatted data on a patient mobile
device.
24. The computer-readable medium according to claim 22, wherein the
operations further comprising communicating the formatted data to
an interactive stoma care management platform according to claim
18.
25. A method for stoma care management comprising: (a) measuring at
least one parameter of a stoma effluent received in an ostomy bag;
(b) communicating data on the measured parameter to a stoma care
management software application; (c) converting the data on the
measured parameter into a usable format; and (d) communicating the
formatted data to an interactive stoma care management platform for
analysis and storage.
26. The method according to claim 25, wherein the ostomy bag
comprises at least one measurement communicator attached to the
ostomy bag, wherein the measurement communicator is configured to
receive the measurement data point from the parameter sensor and to
communicate the measurement data point to the stoma care management
software application.
27. The method according to claim 25, wherein the stoma care
management software application is configured to run on a patient
mobile device.
28. The method according to claim 27, further comprising presenting
a visual representation of the formatted data on the patient mobile
device.
29. The method according to claim 25, wherein the interactive stoma
care management platform comprises computer program instructions
for maintaining a patient related database for storing the
measurement data from the stoma care management software
application.
30. The method according to claim 25, wherein the interactive stoma
care management platform comprises computer program instructions
for periodically advising a stoma patient of needed actions as well
as to provide reminders, advice and coaching.
31. The method according to claim 25, wherein the interactive stoma
care management platform comprises computer program instructions
for determining a correlation between the sensor measurement data
and a predefined health metric for the stoma patient.
32. The method according to claim 25, wherein the interactive stoma
care management platform comprises computer program instructions
for adding contextual metadata to at least a subset of the analyzed
measurement data.
33. The method according to claim 32, wherein the contextual
metadata comprises one or more tags that identifies an origin of
the subset of analyzed measurement data within one or more
sub-portals.
34. The method according to claim 33, further comprising
communicating an intervention trigger to the patient mobile device
in dependence on the analyzed measurement data exceeding a
predefined threshold level.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] The present application, pursuant to 35 U.S.C. 111(b),
claims the benefit of the earlier filing date of provisional
application Ser. No. 62/254,475 filed Nov. 12, 2015 and entitled
"Systems and Methods for Providing Comprehensive Care for Stoma
Patients."
BACKGROUND OF THE INVENTION
[0002] Field of the Invention
[0003] This invention is related to systems and methods for
providing comprehensive care for stoma patients. More particularly,
the invention is related to a system for providing a sensor device
for detecting a fill level of a stoma bag fitted over and around a
stoma and a wireless platform in communication with the sensor
device to periodically advise the patient of needed actions.
[0004] Description of the Related Art
[0005] An ostomy is a surgical procedure used to create a small
opening or stoma on the abdominal wall for releasing waste matter
from the bowel or bladder. A stoma appears like a small spout.
Waste matter that comes out of the stoma is collected in an
external ostomy or stoma bag or pouch.
[0006] In a colostomy procedure, the stoma is formed by drawing the
healthy end of the large intestine or colon through an incision in
the anterior abdominal wall and suturing it into place. The portion
of the colon that is cut and extended through the abdominal wall
can be in a number of locations, such as the ascending, the
transverse or the descending portion. If in the descending portion,
the effluent would be more dense and would be more similar to that
of a person who has not had any such procedure. The further up the
intestine, the less absorption would take place, and the effluent
would become more unfamiliar in appearance and consistency.
[0007] In an ileostomy, an opening is made in the belly (abdominal
wall) and the end of the ileum (the lowest part of the small
intestine) is brought through this opening to form a stoma, usually
on the lower right side of the abdomen. In either case, a
collection bag is attached to the stoma. Since the collection bag
is flexible and the extruding section tissue that one attaches to
the collection bag is also flexible, there can be leaks at the
attachment region, particularly as the bag becomes fuller and there
is more fluid pressure from the bag contents at the attachment
region.
[0008] In some cases, for colostomy, ileostomy or urostomy
patients, the stoma may be temporary allowing the bowel or bladder
to heal before the stoma is reversed. The length of time before
reversal varies but most are not reversed before three months. In
other cases, the stoma may be permanent.
[0009] Patients with an ileostomy or colostomy have an impaired
quality of life related to the difficulties involved with having
the external stoma bag and the fact that patients with a stoma have
no control over their release of waste matter. Although patients
with an ileostomy may have a better quality of life as compared to
patients with a colostomy, both procedures limit the range of
activities that recipients are comfortable undertaking. The more
liquid nature of the ileostomy or urostomy effluent, which creates
more fluid pressure at a stoma bag attachment region, can
predispose these patients' to dehydration and their bags to
overfill; whereas colostomy patients, having a higher effluent
consistency, are more susceptible to blockages of the attachment
region (which is narrower than the bag itself).
[0010] These problems are particularly important to patient
populations with long term or permanent colostomy or ileostomy.
Overfilling and breakage/leakage of the collection bag can affect a
patient's ability to function in social environments, go out in
public, have intimate relationships with significant others, and
can interfere with sleep patterns due to high internal output and
nighttime overfilling of the bag.
[0011] One difference in patients with an ileostomy bag is that
because the contents are more liquefied than in a colostomy, the
bag can often be drained several times before it is replaced
whereas a colostomy bag must be replaced every time it is
filled.
[0012] There is a need for a convenient device that can prevent
unexpected bag overfilling, breakage, and nighttime accidents. The
device should be capable of being configured to store and email
output data to the patient's health care providers. The device
should have the potential to reduce ostomy related dehydration
through more accurate volume recording and sharing. The device
should be configured to easily determine the rate of fill of the
bag since this may predict whether a patient is headed toward
dehydration.
SUMMARY OF THE INVENTION
[0013] Embodiments of the invention include a care management
system for providing comprehensive care for stoma patients. The
system includes: A) a sensor or sensing device associated with a
measurement communicator and a data processor; B) a software
application 210 for receiving, storing, and processing the
measurement data communicated from the sensor device; and C) a
wireless stoma care management platform residing on a computer that
maintains a patient related database, correlates the measurement
data with information on external data sources and patient
responses to queries in order to develop a health metric for the
stoma patient, and periodically advises the patient of needed
actions as well as to provide reminders, advice and coaching.
[0014] One embodiment of the invention is an ostomy bag having: a)
an attachment site to a patient stoma; b) at least one parameter
sensor attached to the ostomy bag, wherein the parameter sensor is
configured to measure one parameter of a stoma effluent received in
the ostomy bag; and c) at least one measurement communicator
attached to the ostomy bag, wherein one measurement communicator is
configured to receive a measurement data point from the parameter
sensor and to communicate the measurement data point to a stoma
care management application.
[0015] Another embodiment of the present invention is a system for
assisting a stoma patient with management of an ostomy bag
including: a) a sensor device configured to sense one or more
parameters of a stoma effluent received in the ostomy bag; b) a
stoma care management application for receiving, storing and
processing measurement data communicated from the sensor device,
wherein the stoma care management application is configured to run
on a patient mobile device; and c) a wireless platform in
communication with the mobile device, wherein the platform
comprises one or more portals, and wherein the platform is
configured to maintain a patient related database and a programmed
knowledge module for analyzing information from the database and
one or more external databases.
[0016] According to another embodiment, an interactive stoma care
management platform is provided. The platform includes a memory;
and a processor that executes computer-executable components stored
in the memory to implement the platform The computer-executable
components include: (i) a knowledge module configured to analyze
sensor measurement data received from a stoma care management
software application, wherein the stoma care management software
application is configured to run on a mobile device; and (ii) a
portal configured to add contextual metadata to at least a subset
of the analyzed sensor measurement data. The contextual metadata
comprises one or more tags that identify an origin of the subset of
analyzed sensor measurement data within one or more sub-portals. At
least one sub-portal is configured to communicate an intervention
trigger to a mobile device in dependence on the analyzed sensor
measurement data exceeding a predefined threshold level.
[0017] In another embodiment, a stoma care management software
application is provided. The application may be stored on
non-transitory computer-readable medium. The medium includes
computer-executable instructions that, in response to execution,
cause a computing system to perform operations for stoma care
management. The operations include: interfacing with a sensor
device; and receiving, from the sensor device, a plurality of
sensor measurement data relating to one or more parameters
associated with an ostomy bag for a stoma patient.
[0018] In yet another embodiment, a method for stoma care
management involves: measuring at least one parameter of a stoma
effluent received in an ostomy bag; communicating data on the
measured parameter to a stoma care management software application;
converting the data on the measured parameter into a usable format;
and communicating the formatted data to an interactive stoma care
management platform for analysis and storage.
[0019] The foregoing has outlined rather broadly several aspects of
the present invention in order that the detailed description of the
invention that follows may be better understood. Additional
features and advantages of the invention will be described
hereinafter which form the subject of the claims of the invention.
It should be appreciated by those skilled in the art that the
conception and the specific embodiment disclosed might be readily
utilized as a basis for modifying or redesigning the structures and
systems for carrying out the same purposes as the invention. It
should be realized by those skilled in the art that such equivalent
constructions do not depart from the spirit and scope of the
invention as set forth in the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] For a more complete understanding of the present invention,
and the advantages thereof, reference is now made to the following
descriptions taken in conjunction with the accompanying drawings,
in which:
[0021] FIG. 1 is an illustration of a system for providing
comprehensive care for stoma patients according to an
embodiment.
[0022] FIG. 2 is a schematic illustration of a mobile application
and an interactive platform for providing care for stoma patients
according to an embodiment.
[0023] FIG. 3 is another schematic illustration of the mobile
application and interactive platform for providing care for stoma
patients according to an embodiment.
[0024] FIG. 4A is an illustration of a closed ended ostomy bag.
[0025] FIG. 4B illustrates an open ended ostomy bag both when it is
clipped closed and when it is opened.
[0026] FIG. 4C is an illustration of an ostomy bag mounting plate
or flange.
[0027] FIG. 4D is an illustration of a temporary closed ended
ostomy bag.
[0028] FIG. 5A illustrates one embodiment of a sensor device.
[0029] FIG. 5B is one embodiment of the mounting device with
multiple parameter devices.
[0030] FIG. 6A is an illustration of the sensor device shown in
FIG. 5A mounted on an ostomy bag.
[0031] FIG. 6B is schematic illustration of an embodiment of a
sensor device mounted on an ostomy bag.
[0032] FIG. 6C is an exploded view of one embodiment of a sensor
device.
[0033] FIG. 6D is a schematic side view of a collection bag with
embedded parameter sensors.
[0034] FIG. 6E a sensor device with two parameter sensor arrays
connected to data processors and a measurement communicator.
[0035] FIGS. 7A and 7B are schematic illustrations of a mobile
application configured to detect a fluid measurement in an ostomy
bag according to an embodiment.
[0036] FIG. 7C is an exemplary display screen of a stoma care
management software application according to an embodiment.
[0037] FIG. 8 is an exemplary display screen of a user sub-portal
of an interactive platform according to an embodiment.
[0038] FIG. 9 is an exemplary chat screen for a healthcare
counselor to connect with a stoma patient according to an
embodiment.
[0039] FIG. 10 is an exemplary display screen of a healthcare
counselor sub-portal of an interactive platform according to an
embodiment.
[0040] FIG. 11 is an illustration of a method for providing care to
a stoma patient according to an embodiment.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0041] It is to be understood that the disclosed embodiments are
merely exemplary of the invention, which may be embodied in various
forms. Therefore, specific structural and functional details
disclosed herein are not to be interpreted as limiting, but merely
as a representative basis for teaching one skilled in the art to
variously employ the present invention in any appropriately
detailed structure.
[0042] Referring now to the drawings, and initially to FIGS. 1 and
2, it is pointed out that like reference characters designate like
or similar parts throughout the drawings. The Figures, or drawings,
are not intended to be to scale. For example, purely for the sake
of greater clarity in the drawings, component size and spacing are
not dimensioned as they actually exist in the assembled
embodiment.
Care Management System for Stoma Patients
[0043] Embodiments of the invention include systems and methods for
providing comprehensive care for stoma patients. According to one
embodiment, a system for providing comprehensive care for a stoma
patient includes: a sensor device for detecting a fill level of an
ostomy bag fitted over and around a stoma, wherein the sensor
device is configured to sense one or more parameters of an effluent
received in the bag; communicating the measurements to a stoma care
management software application for formatting and visualization on
a patient mobile device; and transferring the formatted data to an
interactive wireless stoma care management platform, wherein the
platform is configured to maintain a patient related database and
to periodically advise the patient of needed actions as well as to
provide reminders, advice and coaching.
[0044] FIG. 1 shows an embodiment of a care management system 100
for providing comprehensive care for stoma patients. The system 100
includes: A) a sensor or sensing device 120 associated with a
measurement communicator 130 and a data processor 150; B) a
software application 210 for receiving, storing, and processing the
measurement data communicated from the sensor device 120; and C) a
wireless stoma care management platform 200 residing on a computer
that maintains a patient related database, correlates the
measurement data, information on external data sources and patient
responses to queries in order to develop a health metric for the
stoma patient, and periodically advises the patient of of needed
actions as well as to provide reminders, advice and coaching.
Ostomy Pouch and Sensing Device
[0045] Ostomy Pouch. An ostomy is a surgical procedure used to
create a small opening or stoma on the abdominal wall for releasing
waste matter from the bowel or bladder. A stoma appears like a
small spout. Waste matter that comes out of the stoma is collected
in an external ostomy or stoma bag or pouch 110. An ostomy bag,
stoma or collection bag, allows the stoma to drain into a sealed
collection bag while protecting the surrounding skin from
contamination.
[0046] The ostomy bag is typically a water-tight flexible
elastomeric bag that is either a one-piece apparatus (illustrated
in FIGS. 4A and 4D) that attaches directly to the stoma or is a
two-piece apparatus (shown in FIG. 4B) that has a mounting plate
420 (such as shown in FIG. 4C), commonly called a flange, wafer or
baseplate as well the bag. The flange ring 420, shown in FIG. 4C,
is attached mechanically or with an adhesive to the bag. The
two-piece apparatus allows the bag to be exchanged without removing
the flange, as for example temporarily switching to a "mini-pouch"
(shown in FIG. 4D) for swimming or other short-term activities.
[0047] Ostomy bags come as both open-ended bags 430 or closed-ended
bags 410. The open-ended bags 430 have a resealable end 450 that is
sealed with a closure 440. The open-ended bags can be opened to
drain the contents of the bag into a toilet. The open-end 450 of
the open-ended bag is generally rolled over and sealed with a
Velcro-type closure or a simple clip 440. The collection bag is
attached to the stoma. Since the collection bag is flexible and the
extruding section of tissue that one attaches to the collection bag
is also flexible, there can be leaks at the attachment region,
particularly as the bag becomes fuller and there is more fluid
pressure from the bag contents at the attachment region.
[0048] Sensing Device. Referring back to FIG. 1, embodiments of the
present invention have one or more sensor devices 120 attached to
the collection bag. Depending on the type of sensor device 120 and
its attachment to the collection bag 110, the sensor device will
differ in size, shape and function. The device 120 is generally
manufactured from a suitable material, such as a plastic that is
resistant to hospital disinfectant cleaners.
[0049] One embodiment of a sensor device 120 is illustrated in FIG.
5A. The sensor device 120 includes several parameter sensors 510,
such as illustrated in FIG. 5B, and a measurement communicator 530
that stores and transmits each measurement of the parameter being
measured by the parameter sensor 510. The parameter sensors 510 are
in communication with one or more measurement communicators 530.
Thus, a collection bag can be customized by a patient, a health
care provider or a researcher to measure, store, calculate,
communicate, record and/or track one or more desired
parameters.
[0050] The parameter sensor(s) 510 are typically attached to or
embedded within the collection bag 110 or the flange 420. For
example, FIG. 6A illustrates one embodiment of the sensor device
shown in FIG. 5A having a mounting device 520 that is removably
attached to the outside of an ostomy bag via Velcro type attachment
strips 525, a covering with an adhesive side having parameter
sensors (a Band-Aid type of attachment with one or more parameter
sensors substituted for the gauze patch), or insertion into a pouch
on the outside of the bag. The sensor device can be attached
horizontally across one section of the bag as shown in FIG. 6A, or
it can be attached vertically or diagonally to the bag. The
parameter sensors 510 may be mounted in any desired position for
monitoring as long as the parameter sensors are in communication
with the measurement communicator 530.
[0051] The mounting device 520 may have an array of multiple
parameter sensors 510 as illustrated in FIG. 5B and those parameter
sensors may be the same type of sensor or they may be different
sensors. For example, the embodiment of the sensor device
illustrated in FIG. 6B illustrates a sensor device having multiple
types of parameter sensors 512, 514, 516 and 518. Although a
variety of parameter sensors can be used at various locations, it
is important that each parameter sensor 510 is in constant
communication with a measurement communicator 530 via a
communication conduit 630, such as an optical fiber or a wire or
any other communication transport conduit.
[0052] Often, the sensor device is removably attached to the
outside of the ostomy bag 110 so that it can be removed and placed
on another bag. Alternatively, parameter sensors 510 may be
embedded within the bag and disposed with the bag. If the parameter
sensors 510 are embedded in the bag, then the measurement
communicator 530 will typically be removably attached to the
outside of the bag at a site having communication with each of the
embedded parameter sensors 510. In such cases, the measurement
communicator 530 is attached mechanically or with an adhesive to
the communicator attachment site 620 on the ostomy bag 110.
[0053] One embodiment of an ostomy bag 110 with embedded parameter
sensors, shown in FIG. 6D, has at least one outside elastomeric
layer 622 sealed to a section of the bag with at least one
parameter sensor sandwiched between the outside layer and the bag.
Since there may be a number of parameter sensors, of one or more
type, embedded between the outside layer and the bag; there may be
one or more outside layers 622, 624, 626 that are attached to the
outside of the bag. These outside layers may be different sizes and
shapes and will be positioned at different locations on the
bag.
[0054] The outside layers may be open at one end to serve as a
pocket or a pouch for the sensor device 120, or they may be sealed
to the outside of the bag along sections of their perimeter. The
outside layers are designed to protect the parameter sensors 510
and their communication conduits 630, such as an optical fiber or a
wire shown in FIG. 6E, from either physical or chemical damage
during bag use to ensure the communication link between the
parameter sensor 510 and its connection to the measurement
communicator 530 at the communicator attachment site 620. Embedded
parameter sensors may be particularly useful for patients that
empty their bag and reuse it multiple times.
[0055] Types of Sensors. Although the description continues with
references to "a" (single) sensor device, it should be understood
that different sensor devices and different parameter sensors may
be employed to provide and communicate different sensed parameters.
A non-exhaustive list of different example types of parameter
sensors 510 may be employed for measuring the following:
[0056] Volume: a) Flex/bend and stretch sensors contained within an
adhesive strip can detect changes in resistance, as the flex and
stretch sensors bend or are extended the electrical resistance
changes and is recorded by the measurement communicator; b)
Pressure sensors can measure the pressure exerted by the filling
bag and thus with the known volume of the bag, this measurement is
reported as the volume of bag content; and c) Level measuring
sensors can be placed at defined vertical locations on the bag such
that capacitance sensors, ultrasonic sensors or a microwave
propagation phase shift sensors can measure the liquid and solid
level of the bag as it fills.
[0057] Turbidity: a) IT optical backscattering sensors having an
embedded small IR LED in the parameter sensor with photodiodes
surrounding the IR LED to measure the backscattering of the IR
light from the particles in the bag with which the IR light
interacts. Such measurements can provide the size of the particles
and report on the turbidity (and thus consistency) of the contents;
and b) Ultrasonic sensors (such as Doppler sensors) can be used as
an alternative to the IR optical backscattering, the ultrasonic
sensors can also be used to measure the contents and consistency of
the stoma effluent in the bag.
[0058] Odor-olfaction: Nanosensor (or "e-nose") circuits can be
used to measure a variety of odors, for example a methane and
ammonia sensor can report any odors or leakages within the
immediate environment of the parameter sensor.
[0059] Temperature: A differential temperature sensor can be used
to record changes in the temperature of the bag and/or the stoma
effluent or bag contents.
[0060] Liquid Flow: A flow sensor can be placed at the top of the
bag and/or at the opening of the bag proximal its attachment to the
stoma to measure all stoma effluent flow into the bag.
[0061] Leakage: A parameter sensor that uses ink jet electrodes
printed on paper can be used to measure leakage. The sensor paper
is placed at the site of bag attachment to the stoma with the
sensor paper surrounding the stoma or attached to the flange 420.
As the paper gets wet, from leakage, the electrodes changes
resistance and report this to the communicator 530.
[0062] Activity: A tri-axis or multi-axis accelerometer chip may be
embedded on a circuit board within the measurement communicator 130
of the sensor device to report on movement and activity. The
measurement communicator is configured to receive data from the
accelerometer chip. Using the data, the direction/orientation of
the patient's body can be calculated. This facilitates the
determination of whether the patient is walking, lying down,
sitting up with his body in an upright position, or leaning forward
or any other direction. This information can be used to evaluate
the fluid level measurements.
[0063] In one embodiment, the parameter sensor 510 is a soft,
ultrasensitive wireless stretch sensor. In another embodiment, the
parameter sensor 510 may be a capacitive sensor. Capacitive sensors
may be used to detect and measure fluid levels in the collection
bag 110. In yet another embodiment, such as shown in FIG. 6B, one
parameter sensor 518 may be for detecting leakage, one parameter
sensor 512 may be for turbidity, one parameter sensor 514 may be
for temperature, and one parameter sensor 516 may be to report
specific movements.
[0064] In one embodiment, as the bag 110 fills up, the parameter
sensor 510 can measure, through the resistance of the strip, the
bending and stretching of the bag. In another embodiment, the
parameter sensor 510 is clipped to the edges of the bag 110 to
sense the bending and stretching and conformational changes of the
bag 110 as it fills up.
[0065] In yet another embodiment, the parameter sensor 510 is a
capacitive fluid sensor. Capacitive fluid sensors can measure the
change in capacitance as the fluid levels rise. This embodiment can
include two electrodes in a circuit or an array of sensors running
vertically up and down the bag to measure increasing volume levels.
The capacitance between the two electrodes is different when there
is air (a non conducting medium of low dipole), versus water
(having a higher dielectric constant). Therefore, as measurements
are taken at predetermined set time intervals the fluid levels
rises and the bag fills up. In this case the fluid would have
slightly different dielectric properties than water since it is
urine and waste and there will be a detectable change along the
many electrodes that would measure specifically where the fluid is
in the bag.
[0066] Measurement Communicator.
[0067] Every parameter sensor 510 must communicate the data
gathered by the parameter sensor to a measurement communicator 530
where it is gathered, identified with a particular parameter sensor
device 510 and typically processed before being further
communicated to the platform 200. The sensor device 120 includes at
least one parameter sensor 510, at least one data processor 150,
and at least one measurement communicator 530 that stores and
transmits each measurement of the parameter being measured by the
parameter sensor 510.
[0068] In one embodiment a single parameter sensor 510 is in
communication with a single measurement communicator 530. In other
embodiments, multiple parameter sensors are in communication with a
single measurement communicator. For example, one embodiment shown
in FIG. 6E has two parallel arrays 640 and 645 where each array has
multiple parameter sensors of a single type. Sensor array 640 has
several parameter sensors 514, whereas sensor array 645 has several
parameter sensors 512. Each sensor in each array must communicate
with a data processor and a measurement communicator 130. The
embodiment shown in FIG. 6E shows that each sensor 514 in the
sensor array 640 communicates with a data processor 152 through a
communication conduit 634, while each sensor 512 in the sensor
array 645 communicates with a data processor 154 through a
communication conduit 632. The data processors 152 and 154 may be
the same or different and the communication conduits 632 and 634
may be the same or different. For example, the communication
conduits 632 and 634 may be wire connections or communication
conduit 632 may be wire connections and communication conduit 634
may be optical fibers. In another embodiment (not shown), the
sensors may wirelessly communicate with the data processors.
[0069] FIG. 6C is an exploded view of one embodiment a sensor
device 600. The measurement communicator 530 has an upper 602 and a
lower 604 end cap that are fitted together to enclose a data
processor having a control board 606 such as a PCU (Programmable
Control Unit) or a PCB (Printed Circuit Board), a battery retainer
608, and a battery 610. The mounting device 520 has an array of
parameter sensors 510. In addition, the sensor device 600 may
optionally have a parameter sensor such as an odor sensor 618 that
protrudes through the upper end cap. Each parameter sensor
communicates with the data processor or control board 606 that
collects, identifies and processes each measurement from each
parameter sensor and the broadcasts the measurement through the
measurement communicator to the mobile application 210. Typically,
the data processor 150 receives the measurement signal from a
parameter sensor 510, reformats the raw measurement signal and adds
an identifier such as the time of the measurement and/or the
identity of the specific parameter sensor that took the
measurement.
[0070] The measurement communicator 530 is designed such that when
the mounting device 520 is assembled with the measurement
communicator that the parameter sensors mounted on the mounting
device or embedded within the bag are in communication with the
control board 606. Whenever an odor sensor 618, or any other
sensor, is included in the sensor device, that parameter sensor
must also have a communication conduit 630 aligned to allow
communication between the parameter sensor and the control
board.
Stoma Care Management Software Application
[0071] According to an embodiment, measurement data such as a rate
of fill or fill level measurement data from the bag 110 is
periodically transmitted to a stoma care management software
application. FIG. 2 illustrates an interactive platform for stoma
care management 200 according to an embodiment of the present
disclosure. As shown in FIG. 2, the stoma care management software
application or mobile application may be configured to run on any
portable or mobile device 210. The stoma care management software
application may be available for download through app stores or
distribution platforms. The mobile device 210 may include a smart
phone or a tablet computer. The stoma care management software
application includes computer program instructions for receiving
the measurement data from the measurement communicator 130 via the
data processor 150. The measurement data is transmitted from the
data processor 150 in binary format. The stoma care management
software application includes computer program instructions for
converting the transmitted data into a suitable format (for
example, hexadecimal format). The stoma care management software
application further includes computer program instructions for
interpreting the formatted measurement data using a dictionary
application. The stoma care management software application further
includes computer program instructions to present a visual
representation of the fill levels of the collection bag 110. The
visual representation may be displayed on a display screen of the
mobile device 210.
[0072] The measurement data is transmitted from the measurement
communicator 130 to the mobile device 210 wirelessly through
passive RFID, or a low energy Bluetooth radio or a GSM radio
transmission, or direct transmission through the network to a
server using wireless networks (a GSM or CDMA mobile system). The
formatted measurement data is transmitted to a platform for stoma
care management 200 where it is analyzed and intervention triggers
are activated as required.
Interactive Platform for Stoma Care Management
[0073] According to another embodiment, a computerized platform
200, methods and computer-readable media are provided for stoma
care management. By way of example and not limitation, the stoma
care management software application running on a mobile device
periodically receives measurements from the mobile application via
the data processor and the measurement communicator on the fill
levels of the collection bag. The measurements are interpreted by
the stoma care management software application and the data is
transferred to an interactive platform 200 for stoma care
management. The platform includes a knowledge module 230. The
knowledge module is a data repository and is further configured to
analyze the data received from the stoma care management software
application and transfer the results of the analysis to a server or
portal 240 for stoma care management. The portal includes a user
sub-portal that is configured to provide real-time information and
intervention to the stoma patient.
[0074] The platform 200 can be configured to deliver personalized
care solutions for a stoma patient using information from a number
of devices (including the aforementioned sensor device 120 and
measurement communicator 130). In one or more embodiments, the
platform 200 can facilitate the interaction between a stoma
patient, a caregiver, a financial/claims administrator and any
other authorized user. Access to the platform 200 may be controlled
by a system administrator. Only users with authorized credentials
may be allowed access to the platform 200. For example, the memory
may include cloud storage that stores profiles for one or more
stoma patients that define at least one of access privileges or
preferences for respective patients.
[0075] The platform 200 can include a multitude of interrelated
elements. Embodiments of the platform 200 can be implemented to
some extent as software modules installed and running on one or
more processing systems (`computer`), such as servers,
workstations, tablet computers, PCs, personal digital assistants
(`PDAs`), smart phones, and so on. The processing systems may
include at least one computer processor as well as a memory (not
shown).
[0076] The processor can represent one or more general-purpose
processing devices such as a microprocessor, central processing
unit, or the like. More particularly, the processor may be a
complex instruction set computing (CISC) microprocessor, reduced
instruction set computing (RISC) microprocessor, very long
instruction word (VLIW) microprocessor, or a processor implementing
other instruction sets or processors implementing a combination of
instruction sets. The processor may also be one or more
special-purpose processing devices such as an application specific
integrated circuit (ASIC), a field programmable gate array (FPGA),
a digital signal processor (DSP), network processor, or the like.
The processor can be configured to execute instructions for
performing the operations and steps discussed herein.
[0077] The computer can also include a computer readable storage
medium on which is stored an appropriate operating system (not
shown). A computer readable storage medium may be, for example, but
not limited to, an electronic, magnetic, optical, electromagnetic,
infrared, or semiconductor system, apparatus, or device, or any
suitable combination of the foregoing. More specific examples (a
non-exhaustive list) of the computer readable storage medium would
include the following: an electrical connection having one or more
wires, a portable computer diskette, a hard disk, a random access
memory (RAM), a read-only memory (ROM), an erasable programmable
read-only memory (EPROM or Flash memory), an optical fiber, a
portable compact disc read-only memory (CD-ROM), an optical storage
device, a magnetic storage device, or any suitable combination of
the foregoing. One or more sets of instructions (e.g., software)
embodying any one or more of the methodologies or functions
described herein may also be stored on the computer-readable
medium. The instructions may further be transmitted or received
over a network.
[0078] Instructions or program code embodied on the computer
readable medium may be transmitted using any appropriate medium,
including but not limited to wireless, wireline, optical fiber
cable, RF, etc., or any suitable combination of the foregoing.
Computer program code for carrying out operations of the present
invention may be written in an object oriented programming language
such as Java, Smalltalk, C++ or the like. However, the computer
program code for carrying out operations of the present invention
may also be written in conventional procedural programming
languages, such as the "C" programming language or similar
programming languages.
[0079] The memory may include both volatile random access memory
(`RAM`) and some form or forms of non-volatile computer memory such
as a hard disk drive, an optical disk drive, or an electrically
erasable programmable read-only memory space (also known as
`EEPROM` or `Flash` memory). The memory can be connected to the
processor and to other system components. The platform 200 may also
include one or more input/output network interface device (not
shown) for implementing user-oriented input/output through software
drivers and hardware for controlling output to input/output devices
such mobile devices 210 through a network. The platform 200 can be
accessible to any number of other devices, user machines and users
through a network. The other devices can be mobile phones, desktop
computers, laptop computers, handheld computers or similar
computing device. The network can be local area network (LAN), such
as an intranet within a company, a wide area network (WAN), such as
the Internet or similar communication system. The network can
include any number of networking and computing devices including
any number of wired and wireless devices. The network may include
connections, such as wire, wireless communication links, or fiber
optic cables.
[0080] Knowledge Module. The platform 200 may include a knowledge
module 230. The knowledge module includes a database comprising
patient related data 220. The database 220 is a data repository for
measurement data received from the measurement communicator 130.
The database 220 can be a local storage unit or a remote storage
unit. The database 220 may be a magnetic storage unit, optical
storage unit, solid state storage unit or similar storage unit. The
database 220 can be a monolithic device or a distributed set of
devices. The database 220 can further include information on sensor
identification numbers, the time period with ostomy, how frequently
the stoma bag is changed and/or replaced, the volume, activity,
usual consistency of the effluent/waste, problem areas with the
bag, meal tags, calculated values, tips, alerts, rules, messaging,
personalized meal plans, user input data relating to foods consumed
and activity level and duration, etc.
[0081] The knowledge module 230 may be implemented as one or more
sub-modules operating in separate software layers or in the same
layer. These one or more sub-modules may be incorporated as part of
the operating system, in the software stack, in hardware, in
firmware (such as in the BIOS), or in any other manner as will
occur to those of ordinary skill in the art. The knowledge module
230 processes information from the database 220 and one or more
external data sources to determine personalized clinical and
nutritional decision analytics. The external data sources can
include a laboratory, insurance companies, media companies, call
enters, care providers, account administrators, durable medical
equipment (DME) suppliers, and other sources.
[0082] The knowledge module 230 may include one or more algorithms
that provide both content and personalized rules to provide
feedback to the patient in real time. For example, the knowledge
module 230 may include code for predicting trends based on effluent
parameters and summary snapshots (for example, average flow
changes). The information and analysis may be stored in database
220. The knowledge module 230 may include instructions to implement
one or more rules. For example, the rules may pertain to a daily
meal or activity plan for the patient, a matching of the patient to
a coach, nutrition guidance, client reports and predictions, member
health profiles and video/chat sessions.
[0083] The patient's body mass index (BMI) and basal metabolic rate
(BMR) are also preferably determined by the knowledge module 230.
These metrics (and the type of patient ostomy) are transmitted to
the database 220, which also includes the user's personalized
health profile and preferences. Various parameters are considered
in determining recommendations, educational messages, and
directives to the patient. The knowledge module 230 then processes
data measurement to determine useful patient information (e.g.,
estimated fill rate to send alerts of needed bag changes, etc.) and
transmits related information to the user, including information
relating to nutrition, exercise advice and treatment decisions.
[0084] Portal. The platform 200 further includes a secure server or
portal 240. The portal is typically web-based. The portal 240
receives analyzed data content from the knowledge module 230. The
portal 240 provides one or more interfaces for reporting and
displaying the data from the knowledge module 230. The portal 240
can be used to create and display profiles of individual
members/patients. The portal 240 can be used to display information
on a patient's clinical progress, medications, nutritional status
etc. The portal 240 communicates with mobile devices so that the
patient may view the desired patient related data on a mobile
device. In one embodiment, the portal 240 may be accessed from the
same mobile device 210 that is configured to run the stoma care
management software application.
[0085] The portal 240 can be used to track patient preferences,
especially those relating to diet and exercise. The tracking of
favorites and the updating, analyses and recommendations based on
patient favorites is normally a data-intensive function. The
tracking and updating of patient favorites is generally based on
information either gathered from the patient at an interview, or
based on responses to queries from the patient. Accordingly, the
tracking, updating, analyses and recommendations based on favorites
are normally performed by the knowledge module 230, following
transmission of real-time information on fill rate projections from
the mobile device 210. The recommendations for eating can be highly
specific and personalized (e.g., eat X calories of carbohydrates
selected from "your favorites" mashed potatoes and pinto beans; Eat
X calories of lean protein, selected from "your favorites" shrimp
and egg whites). Similarly, recommendations for exercise can
include recommendations for exercise duration and exertion
level.
[0086] Furthermore, several messages can be sent based on the
projected fill rate (e.g., the bag is X hours from needing a change
or that the bag is full and needs immediate changing). Or, the
patient can be directed to stop eating after a certain time or the
patient may be directed to stop or start exercising. Once projected
fill rates generate a profile for the patient--where all these
factors are tracked and a projected fill rate is established,
together with a warning system based on the projected volume of
contents within the bag and when it is likely to be full.
[0087] The portal 240 may also track the patient's fluid intake
rates and actual outflow (for example, the volume of urine
collected in the bag). Using predictive algorithms, the system 200
can predict rate of fill and other calculations. These calculations
may be used to target nutrition and "IN" and "OUT" fluid levels to
ensure that the patient does not suffer from dehydration.
Dehydration happens when a patient loses more fluid they take in.
When this happens, their body doesn't have enough water and other
liquids to carry out its normal functions. Dehydration is a common
problem for stoma patients, particularly those who have had an
ileostomy. Normally, the large intestine absorbs water back into
the body as solid waste goes through. An ileostomy keeps food and
liquid from entering the large intestine, so water cannot return to
your body increasing the likelihood of dehydration. Patients that
do not get enough liquid can end up in to the emergency room or
back in the hospital. In fact, one of every five new ileostomy
patients is readmitted to the hospital for dehydration. The
tracking and recording of a patient's fluid intake and output by
the knowledge module 230 can help the patient control their fluid
balance and can be very helpful in developing patient alerts and
advice from the patient's health care provider.
[0088] A number of factors can contribute to the volume /rate of
fill/ quality of effluent collected in the collection bag.
Therefore, the portal 240 is also configured to provide
personalized nutritional, lifestyle, exercise, and educational
information to guide the patient such that they may have a better
quality of life. The coaching may be provided by a specialized
coach, or computerized program, such as a "Health Sherpa.RTM.", a
medical professional, nutritionist, or a caregiver. Long term
coaching may include review through the patient's healthcare
provider and may involve providing a personalized plan of treatment
with the information collected. Therefore, the system 200
facilitates patient- centered health care delivery and it can also
empower the patient in making educated decisions.
[0089] The platform 200 and its ability to communicate with mobile
devices and various computers or processors provides both short and
long term benefits. The short term advantages of this platform may
include real-time alerts so that there is no overfilling and/or
bursting of the bag during the day or when the patient is sleeping;
real-time feedback that includes dietary and nutritional
information and liquid intake to help regulate every day health;
reference to trends on bag volume; aid in meeting nutrition
requirements and the absorption of foodstuffs; and the enablement
of individual reporting and monitoring of ostomy output. The
platform can also facilitate remote tracking by health care
professionals by allowing hospitalized patients and nursing
stations with multiple ostomy patients (such as an oncology
section) to automatically alert the nursing station that a bag
needs changing. The constant monitoring that tracks the output and
predicted fill rates of multiple patients can help with the care
and management of hospitalized patients. This can reduce the
reliance on stoma care nursing staff.
[0090] Furthermore, this can provide physicians with concrete
evidence of bowel activity prior to discharge. Additionally, it may
reduce a length of stay in the hospital for new ostomy patients
with more real time data and nutritional counseling prior to
discharge.
[0091] The long term advantages of the care management system 100
for stoma patients include the conservative utilization of ostomy
bags based on actual fill rates rather than arbitrary scheduled
changes; the reduction of skin irritation and infections by
preventing leakages and bursting of a bag; the actual measurement
of fluid intake and output to reduce dehydration events and reduce
hospital admissions; patient empowerment by allowing patients to
follow their own health care trends to optimize their nutritional
intake based on actual measurement data of food volume/hr,
volume/day and the tagging of food volumes at meal times.
[0092] FIG. 3 represents an embodiment 300 of the platform for
stoma care management. The fluid levels in a collection bag of a
stoma patient/participant are measured on a periodic basis. The
measurement data is transmitted to a stoma care management
application running on a mobile device 210 for formatting and
visualization. The formatted measurement data is transmitted to the
platform for stoma care management.
[0093] The platform includes a knowledge module 230. The knowledge
module 230 differs from a standard database since in this case
further knowledge or informational data may be derived from
existing knowledge using inference, analysis and continual
monitoring data from the patient. Thus, the knowledge module 230 is
a data repository and a "care" analysis engine. The knowledge
module 230 can include a database or a data repository for the
formatted measurement data. As shown, the knowledge module 230 can
also receive data from and transfer data to an external database
310. The external database 310 may include data from various
sources, such as laboratories, insurance companies,
hospitals/clinics, media companies, 24/7 call centers/caregivers,
account administrators, and other sources. The data from the
external database 310 can be extracted and transferred to the
knowledge module 230 using dynamic APIs. A suitable interface can
be used to edit the knowledge module; for this purpose, the
interface exposes a set of APIs in corresponding libraries. These
APIs allow submitting commands for adding, removing, or updating of
data in the knowledge module 230.
[0094] The knowledge module 230 may further include computer
program instructions for analyzing the formatted measurement data
from the stoma care management software application and data
received from external database 310 to provide a knowledge base and
healthcare advocacy information for the stoma care patient. The
knowledge module 230 can also include computer program instructions
to communicate the analyzed data in real-time to a secure portal
240.
[0095] The portal 240 may include a plurality of sub-portals. For
example, the portal 240 may include, without limitation, an
Employer's Portal 320A, a Health Plan/Consultant's Portal 320B,
Health Sherpa/Caregiver Portal 320C and a User Portal 320D. The
portal 240 is configured to add contextual metadata to at least a
subset of the analyzed sensor measurement data. The contextual
metadata can include one or more metatags that identifies an origin
of the subset of analyzed sensor measurement data within the one or
more sub-portals. The contextual metadata further comprises at
least one of a unique identifier associated with a collection bag
for the stoma patient, the patient name, a measurement time and a
measurement date.
[0096] The Employer's Portal 320A may be configured to receive data
from the knowledge module 230 that is relevant to an employer of a
stoma patient. For example, the Employer's Portal 320A may include
aggregate HIPAA information, compliance reports, performance
dashboard, and other related information.
[0097] The Health Plan/Consultant's Portal 320B may be configured
to receive data from the knowledge module 230 that is relevant to a
health plan manager/consultant. For example, the Health
Plan/Consultant's Portal 320C may include personal health records,
financial administration records, performance metrics, and other
related information.
[0098] The Health Sherpa/Caregiver Portal 320C may be configured to
receive data from the knowledge module 230 that is relevant to a
counselor/caregiver of a stoma patient. For example, the Health
Sherpa/Caregiver Portal 320C may include clinical summaries,
electronic medical records, prescription information, lab records,
personal health records, clinical notes, clinical alerts,
information on health coaching and previous coaching sessions with
the patient, assessment tools, intervention tools and other related
tools and data.
[0099] The User Portal 320D may be configured to receive data from
the knowledge module 230 that is beneficial to a stoma patient. The
User Portal 320D (and any of the other portals 320A-C) is an
interactive portal and it may be accessible from the Internet or as
a mobile software application. The User Portal 320D is configured
to receive a plurality of information from the patient on a
periodic basis. For example, the user can input how s/he feels on a
daily basis. The User Portal 320D is further configured to provide
information on daily diet and exercise plans, on-demand and
schedule videos and chat sessions with the Health Sherpa and
caregiver team, education and feedback, personalized lifestyle and
behavioral resources, progress status to goals and other related
information. Advantageously, the User Portal 320D is configured to
provide alerts and reminder. These can be transmitted to the
patient's mobile device 210 or on another computing device and may
be presented via application software. Alternatively, the
information may be contained in text messages, electronic mail
messages or other general-purpose application software resident on
the mobile/computing device. The User Portal 320D is also
configured to provide real-time interventions using a personalized
user profile for the patient.
[0100] As shown in FIG. 8, information for identifying a patient,
such as email, user id, phone, first and last names, medical
condition, age, company name are entered in the user portal 240. A
"Health Sherpa.RTM." may be matched with each patient. Information
on the Sherpa may also be entered in the portal 240. Additional
information such as the patient's weight, height, daily diet and
exercise plans, daily tasks, daily or weekly health status, stress
levels, etc. may also be entered in the knowledge module. The
portal 240 can be configured to allow the user (for example, the
Sherpa) to message the user, retrieve the user profile and
contacts, etc. The portal 240 may use an email authentication
method, for patient authentication. Other authentication methods,
such as authentication of the mobile device, are also
applicable.
[0101] The portal 240 can be configured to facilitate a real-time
messaging or chat session between the patient and the Health
Sherpa.RTM.. An exemplary display is shown in FIG. 9. Also, as
shown in FIG. 10, the portal 240 is configured to allow the user to
determine the number of sessions in queue and to access
predetermined information on previous coaching sessions with the
patient.
[0102] A high-security firewall (not shown) is used to provide a
secure communication channel between the knowledge module 230 and
the portals 240 and mobile application 210. The users/patients are
required to authenticate themselves via an authentication
layer.
Effluent Measurement
[0103] As described earlier, the measurement communicator 530 is
configured to transmit stored effluent/fluid measurement data to a
mobile device 710. This enables a patient to conveniently access
information on the fluid levels in the collection bag. As shown in
FIGS. 7A and 7B, a mounting device 520 is attached to a collection
bag (for example, an ostomy bag) 110. The mounting device 520
includes a plurality of fluid sensors 510. A measurement
communicator 530 is configured to receive and transmit data from
the fluid sensors 510.
[0104] As shown, four fluid sensors, A, B, C and D are disposed
along the length of the mounting device 520. The sensors A-D
measure four levels of fluid inside the collection bag 110. When
the measurement communicator 530 is powered, it goes into an
advertising mode and looks for a suitable mobile device to pair
with. A predetermined communication method, for example, Wi-Fi or a
Bluetooth Low Energy (BLE) protocol can be used to achieve
communication between the measurement communicator 530 and a
suitable mobile device 710. The mobile device 710 can be mobile
phone or a table PC. The mobile device 710 is configured to receive
data notifications from the measurement communicator 530. The
mobile device 710 can be configured with or download a customizable
dictionary application. In one or more embodiments, the
manufacturer of the sensor device 110 can provide the dictionary.
The dictionary is used to define the values and read the parameter
data transmitted by measurement communicator 530. The measurement
communicator 530 can utilize the communication method of the mobile
device 710.
[0105] After the connection is made, the measurement communicator
530 can start sending data notifications periodically to the mobile
device. For example, the measurement communicator 530 can send data
notifications every 10 minutes. The data format may be binary. The
data can include measurements of one or more parameters, such as,
fluid level data (gathered from the fluid sensors) and the X, Y and
Z orientation of the patient (gathered from an accelerometer). The
data may be transmitted with a predefined delay. For example, the
delay may be less than 100 milliseconds. The measurement
communicator 530 sends this data out as a notification and controls
the frequency of broadcasts.
[0106] The mounting device 520 can be characterized by a unique
identifier. When the sensor device 120 is connected to the mounting
device 520, it reads the identifier and recognizes the mounting
device 520. This data is also transmitted to the mobile device 710
with the rest of the data. Each collection bag 110 can be
identified uniquely because the mounting device 520 is attached to
the collection bag 110. Therefore, when the patient changes the
collection bag 110, the change can be easily tracked.
[0107] The data transmitted to and saved on the mobile device 710
further includes the time stamp of each measurement. The time stamp
serves as a unique identifier for each measurement. The time
interval between two measurements is predefined. As such, this time
stamp enables the calculation of how many measurements did not
reach the mobile device 710.
[0108] The measurement communicator 530 can also calculate the rate
of filling of the collection bag 110 for each patient. This
calculation can be used to extract each patient's pattern of bag
filling and therefore make a prediction of when the current bag
will be filled up and alert the patient to any abnormalities.
[0109] The data saved on the mobile device 710 also includes the
measurement of the detected parameter (for example, fluid level in
the collection bag and the measurement of the accelerometer).
[0110] As shown in FIG. 7C, the measurement of fluid levels can be
visually represented on the mobile device 710. The measurement can
be dynamically refreshed whenever there is a change in fluid
levels. The fluid level visual representation provides the patient
with an instant feedback mechanism about his bag filling. The fill
rate can also be shown along with an estimate of when the bag needs
to be changed.
[0111] As shown in FIGS. 7A and 7B, a value can be sent from the
measurement communicator 530 to the mobile device 710 to indicate
the fill level of the collection bag 110. For example, as shown in
FIG. 7A, since the collection bag 110 is empty a corresponding code
in binary format is transmitted to the mobile device 710. As shown
in FIG. 7A, the mobile device 710 can display a message that none
of the sensors are covered, that is, the bag 110 is substantially
empty. FIG. 7B shows the fluid level covering all the sensors. As
such, a corresponding code is transmitted to the mobile device 710.
The mobile device 710 can display a corresponding message that
states that all sensors are covered.
[0112] After the measurement is received by the mobile device 710,
it is read in hexadecimal format and compared against the values
provided in the dictionary to determine that the collection bag 710
is empty or full.
[0113] In another embodiment (not shown), the measurement
communicator is configured to receive data from an accelerometer.
Using the data, the direction/orientation of the patient's body can
be calculated. This facilitates the determination of whether the
patient is lying down, sitting up with his body in an upright
position, is leaning forward or any other direction. This
information can be used to evaluate the fluid level measurements.
For example, if there is a sudden rise in fluid level, the
accelerator's measurements can be used to identify the reason for
the same. If the accelerometer's measurements indicate that the
increased fluid level occurred when the patient was leaning
forward, an alert may not be raised. Otherwise, if the
accelerometer's measurement indicates that the patient had his body
in a straight or upright position, then the interpretation is that
a medical reason may have caused the sudden rise in fluid levels.
This results in an alert being transmitted to the mobile device to
inform the patient of his condition. After sending the data packet,
the measurement communicator 530 goes into a deep sleep mode for a
set time period to conserve battery power.
Method for Providing Comprehensive Care
[0114] An exemplary embodiment for a method of providing
comprehensive care to a stoma patient is illustrated in FIG. 11. As
shown, the method involves measuring the effluent (or any other
parameter) levels in a collection bag to determine bag fill levels
1110. The fill levels can be measured at predetermined time
intervals. For example, the fill levels can be measured every 250
milliseconds. an exemplary embodiment, effluent levels may be
measured to determine 0%, 25%, 50%, 75% and 100% fill information.
The measurements can be communicated to a mobile device using a
wireless communication method.
[0115] As described earlier, the mobile device may be provided with
an application that includes a dictionary to convert the
transmitted measurement into hexadecimal values. These values are
compared against the values provided in the dictionary to determine
fill levels of the bag. The application further provides a visual
representation of one or more parameters 1120. The visual
representation may include color coded information, graphs, charts
or icons on the level measurements, rate of filling up, number of
bag changes and number of bags emptied and reused. The visual
representation of the measured parameters allows the patients to
quickly and easily decipher fill levels.
[0116] The measurements are transmitted to a knowledge module where
they are analyzed in real-time 1130. The measurements are compared
with the patient's records stored in a database. If the
measurements are equal to or greater than a predetermined critical
value, an alert is raised 1140. An alert is typically raised when
the patient is suffering from a potentially life-threatening
condition. Any alert mechanism known in the art can be used to
notify the patient. For example, a text message can be sent to the
user to contact a caregiver. The patient can then be guided to
alleviate the potentially dangerous symptoms that caused the
discrepancy in the measurements 1150. Even if the measurements do
not warrant the raising of an alert, they may be analyzed to
determine whether they raise a "To Do" or warning signal. A warning
signal may be raised if the measurements are not equal to or
greater than predetermined critical value but are within a
predefined warning threshold. If a warning signal is also not
warranted, the measurements are saved to the patient profile for
future reference 1160. However, if a warning signal is raised, the
patient may be invited to schedule a session with his Sherpa or
caregiver 1170 and then guided to improve his overall health by
making required adjustments to their diet, exercise, posture, etc.
1190. Alternately, a team of experts reviews the patient's records
1180 and guides the patient to improve his overall health 1190.
[0117] According to another embodiment, a method for determining
the effect of diet, medication and activity on the bag fill rate is
disclosed. This involves creating a plot of fill rate of the
collection bag over a specified period. This further involves: (i)
determining how increases or decreases in the certain foods
(vegetables, meats, dairy, fish or seafood, fruits, etc.) correlate
with increases or decreases in fill rate; (ii) correlating
increases or decreases in fluids, including water, fruit juice,
carbonated beverages, alcohol, and caffeine, with fill rate; (iii)
determining if any particular combinations of foods or fluids cause
increases or decreases in fill rate; (iv) correlating use of
medications or supplements with fill rate; and (v) determining how
increases or decreases in activity correlate with increases or
decreases in fill rate. In one embodiment, the individual BMR and
BMI may be determined to find the bag fill rates and to compile a
set of warning messages to be transmitted to the patient. After the
results are tabulated, a patient is provided with education and
information, in real time, on managing their diet, medication and
activity levels.
[0118] Because each individual's unique diet, activity level and
physiology (including Body Mass Index and Basal Metabolic Rate) can
affect the fill rate and fill levels, a further preferred
embodiment involves compiling, at the user portal, the user diet,
activity and fill rate information over time, and then establishing
projected individual fill rates based on such information (and
other known personal information such as BMI and BMR). The
projected fill rate is continuously updated over time as data is
accumulated. The updating is needed as the projected fill rate is
expected to change over time with a user's changing physiology. As
a database of projected individual fill rates grows, it allows a
more accurate prediction of fill rates for new patients, for whom
there is no prior fill rate information. Thus, increased
reliability of projected fill rates for new patients is a
significant benefit of one preferred embodiment.
[0119] In another aspect, the invention relates to uniquely
tailored advice and recommendations, particular on diet, based on
patient preferences. The advice and recommendations are continually
updated and further refined as new information on preferences is
added by the user. The individual tailoring of recommendations and
advice is performed in view of the user's preferences, limitations
and individualized risk assessment as continually updated.
[0120] The system may include algorithms that can sort through
patient preferences for diet and exercise to provide uniquely
tailored advice, recommendations and education for the patient. The
number of selections by the algorithm quickly increases as the
patient continues to provide feedback, leaving a set of
instructions which is so detailed as to essentially be a unique
code for the patient.
[0121] In one or more embodiments, the method involves
progressively personalizing the system for each user using a
Progressive User Personalization, or PUP, process. Because no two
individuals are alike, the Progressive User Personalization, or
PUP, can customize the knowledge module to meet the requirements of
each individual user. PUP starts with the individual (not the
group) and creates a personalized experience for the user, an
experience that continually builds on experiential use of the
system and input into the database. Profiles are created, risks are
stratified, program results are tracked and measured, interventions
are designed based on the experience, and the individual's database
become more personalized and tailored to fit their needs and
lifestyle delivering content, tips, messages, and relevant
information to exploit the "teachable moment" to lead to
long-lasting behavior change. The programs are not static but are
interactive and expressly tailored to an individual's needs. PUP
feeds back rich content to engage individuals to manage their own
health, and provides the connectivity and coordination that
individuals need to navigate within healthcare system. The
technology combines the key elements of simplicity, accessibility
and convenience, engagement and community, and tracking and
measuring to effect meaningful interventions. PUP is embedded into
the program to provide constant virtual health and wellness
coaches.
[0122] The detailed description presented above is discussed in
part in terms of procedures which may be executed on a computer, a
network or a cluster of computers.
[0123] These procedural descriptions and representations are used
by those skilled in the art to most effectively convey the
substance of their work to others skilled in the art. They may be
implemented in hardware or software, or a combination of the
two.
[0124] A procedure is here, and generally, conceived to be a
sequence of steps leading to a desired result. These steps are
those requiring physical manipulations of physical quantities.
Usually, though not necessarily, these quantities take the form of
electrical or magnetic signals capable of being stored,
transferred, combined, compared, and otherwise manipulated. It
proves convenient at times, principally for reasons of common
usage, to refer to these signals as bits, values, elements,
symbols, characters, terms, numbers, objects, attributes or the
like. It should be noted, however, that all of these and similar
terms are to be associated with the appropriate physical quantities
and are merely convenient labels applied to these quantities.
[0125] Further, the manipulations performed are often referred to
in terms, such as adding or comparing, which are commonly
associated with mental operations performed by a human operator. No
such capability of a human operator is necessary, or desirable in
most cases, in any of the operations described herein which form
part of the present invention; various operations described herein
may be automatic machine operations. Useful machines for performing
the operations of the present invention include general purpose
digital computers or similar devices.
[0126] Selected steps of the method may be executed on a general
computer, such as a mainframe computer, personal computer or the
like and pursuant to one or more, or a part of one or more, program
modules or objects generated from any programming language, such as
C++, Java, Fortran or the like. And still further, a step, or a
file or object or the like implementing a step, may be executed by
special purpose hardware or a circuit module designed for that
purpose.
[0127] Aspects of the invention are implemented (in one example) in
a high level procedural or object-oriented programming language to
communicate with a computer. However, the inventive aspects can be
implemented in assembly or machine language, if desired. In any
case, the language may be a compiled or interpreted language.
[0128] The invention may be implemented as a mechanism or a
computer program product comprising a recording medium. Such a
mechanism or computer program product may include, but is not
limited to CD-ROMs, diskettes, tapes, hard drives, computer RAM or
ROM and/or the electronic, magnetic, optical, biological or other
similar embodiment of the program. Indeed, the mechanism or
computer program product may include any solid or fluid
transmission medium, magnetic or optical, or the like, for storing
or transmitting signals readable by a machine for controlling the
operation of a general or special purpose programmable computer
according to the method of the invention.
[0129] The procedures presented herein are not inherently related
to a particular computing environment. The required structure for a
variety of these systems will appear from the description given.
Again, the capabilities of one or more aspects of the present
invention can be implemented in software, firmware, hardware or
some combination thereof.
[0130] One or more aspects of the present invention can be included
in an article of manufacture (e.g., one or more computer program
products) having, for instance, computer usable media. The media
has therein, for instance, computer readable program code means or
logic (e.g., instructions, code, commands, etc.) to provide and
facilitate the capabilities of the present invention. The article
of manufacture can be included as a part of a computer system or
sold separately.
[0131] Additionally, at least one program storage device readable
by a machine embodying at least one program of instructions
executable by the machine to perform the capabilities of the
present invention can be provided.
[0132] The flow diagram depicted herein is just an example. There
may be many variations to the diagram or the steps (or operations)
described therein without departing from the spirit of the
invention. For instance, the steps may be performed in a differing
order, or steps may be added, deleted or modified. All of these
variations are considered a part of the claimed invention.
[0133] The specific systems and methods described herein are
representative of preferred embodiments and are exemplary and not
intended as limitations on the scope of the invention. Other
objects, aspects, and embodiments will occur to those skilled in
the art upon consideration of this specification, and are
encompassed within the spirit of the invention as defined by the
scope of the claims. It will be readily apparent to one skilled in
the art that varying substitutions and modifications may be made to
the invention disclosed herein without departing from the scope and
spirit of the invention. The invention illustratively described
herein suitably may be practiced in the absence of any element or
elements, or limitation or limitations, which is not specifically
disclosed herein as essential. Thus, for example, in each instance
herein, in embodiments or examples of the present invention, any of
the terms "comprising", "including", containing", etc. are to be
read expansively and without limitation. The methods and processes
illustratively described herein suitably may be practiced in
differing orders of steps, and that they are not necessarily
restricted to the orders of steps indicated herein or in the
claims. It is also noted that as used herein and in the appended
claims, the singular forms "a," "an," and "the" include plural
reference, and the plural include singular forms, unless the
context clearly dictates otherwise. Under no circumstances may the
patent be interpreted to be limited to the specific examples or
embodiments or methods specifically disclosed herein. The invention
has been described broadly and generically herein.
[0134] The terms and expressions that have been employed are used
as terms of description and not of limitation, and there is no
intent in the use of such terms and expressions to exclude any
equivalent of the features shown and described or portions thereof,
but it is recognized that various modifications are possible within
the scope of the invention as claimed. Thus, it will be understood
that although the present invention has been specifically disclosed
by preferred embodiments and optional features, modification and
variation of the concepts herein disclosed may be resorted to by
those skilled in the art, and that such modifications and
variations are considered to be within the scope of this invention
as defined by the appended claims.
* * * * *